(168 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
Here's a breakdown of the acceptance criteria and study information for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K132335), based on the provided text.
Important Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical validation of novel performance characteristics. The "device performance" in this context mainly refers to adherence to safety and performance standards already established for ultrasound systems, and the new features (RF wireless, Vector Flow Imaging) are discussed in terms of their safety and equivalence, not necessarily extensive clinical efficacy trials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output | Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non-ophthalmic); Thermal Index (TI) ≤ 6.0 | The system in the modified Flex Focus 1202 is the same as the Flex Focus 1200 and "will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0." It also adheres to AIUM/NEMA UD-2 and UD-3. |
| Clinical Measurement Accuracy | Not explicitly stated as a numerical criterion in the provided text. Implied expectation is that accuracy is maintained consistent with previously cleared devices. | "Clinical measurements and calculations are described and accuracies are provided in the User Information." (No specific values or studies are provided in this document, but implied to be acceptable). |
| Thermal, Mechanical, and Electrical Safety | Conformance to applicable medical device safety standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, IEC 62304, IEC 62359. Biocompatibility of patient contact materials. | "The scanner Flex Focus 1202 has been tested by a recognized Certified Body." and "has been found to conform with applicable medical device safety standards." "Cleared patient contact materials, electrical and mechanical safety are unchanged." |
| RF Wireless Function (New Feature) | No interference with other devices or the ultrasound system itself. Performance to meet "actual user requirements." | "Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured." |
| Technological Equivalence (Overall System) | The device should demonstrate "substantial equivalence" to the identified predicate devices (K081154, K123254) in terms of intended use, modes of operation, indications for use, and technological characteristics. Only minor non-safety/efficacy impacting differences are acceptable. | The document repeatedly asserts substantial equivalence, stating the predicate device has "the same major technological characteristics as the subject device." Minor differences are limited to the optional RF wireless function. |
2. Sample Size Used for the Test Set and Data Provenance
- Acoustic Output, Thermal, Mechanical, Electrical Safety: No specific "test set" sample size in terms of patient data or image data is mentioned. The testing was likely performed on the device hardware itself following established engineering and safety standards. The provenance is internal testing and certification by a recognized body.
- RF Wireless Function: Tested at "five (5) different sites." This refers to locations, and implies device testing rather than patient data.
- Clinical Measurement Accuracy: No sample size or provenance is provided in this document; it states details are in "User Information."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not required or provided for a 510(k) submission seeking equivalence for an existing ultrasound system with minor modifications. The "ground truth" for the performance characteristics discussed (acoustic output, safety, electrical performance) is based on engineering measurements against recognized standards, not expert clinical interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. The reported tests are primarily engineering and safety evaluations against predefined standards, not diagnostic performance assessments requiring clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This 510(k) is aimed at demonstrating substantial equivalence for an updated ultrasound system, not to prove improved clinical effectiveness with or without AI assistance for a specific diagnostic task. The description of the device as an "Ultrasound Scanner" further indicates it's a general imaging tool, not an AI-powered diagnostic aide.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is an ultrasound scanner, which is operated by a human. There is no indication of a standalone algorithm component that performs a diagnostic task without human interaction.
7. The Type of Ground Truth Used
- Acoustic Output, Thermal, Mechanical, Electrical Safety: Ground truth is established by adherence to international and national device safety and performance standards (e.g., AIUM/NEMA UD-2, UD-3, IEC 60601 series, ISO 14971, IEC 62304, IEC 62359). This involves physical measurements and engineering validation.
- RF Wireless Function: Ground truth is implied to be actual user requirements and freedom from interference, measured through testing scenarios.
- Clinical Measurement Accuracy: Not explicitly stated, but for a diagnostic ultrasound, this would typically involve phantoms with known dimensions or comparisons to gold standard clinical measurements. The document refers to "User Information" for these details.
8. The Sample Size for the Training Set
Not applicable. This is not a submission for an AI/CADe device that requires a training set. The device is a traditional ultrasound system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device type.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.